We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction (DanPaCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01348048
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : March 3, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Other: Specialised palliative care (SPC) Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
Study Start Date : May 2011
Primary Completion Date : April 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Specialised palliative care (SPC) group
Patients continue with their standard treatment (typically they receive treatment in one or more hospitals departments and from their GP). In addition, they are offered a consultation in the SPC out-patient clinic (or at home if the patient cannot attend the hospital) as soon as possible and no more than one week after randomization. If possible, each patient will have at least two contacts to the SPC in the trial period.
Other: Specialised palliative care (SPC)
The interventions given by the SPC centres follow the the WHO and the EAPC guidelines for palliative care. It is not possible in advance to describe the interventions more specifically as these will be adjusted to each particular patient. As part of the study the medical records of all patients in the intervention group will be reviewed with the purpose of describing the interventions given for the different symptoms and problems.
No Intervention: Standard care group
Patients continue with their standard treatment. They are instructed to contact either their GP or their hospital department if they feel that additional treatment or care is needed.


Outcome Measures

Primary Outcome Measures :
  1. Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need [ Time Frame: Baseline, 3 weeks and 8 weeks ]
    The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale score that constitutes the primary need. The primary need can be a need related to the following: physical function, role function, emotional function, pain, shortness of breath, lack of appetite and nausea/vomiting.


Secondary Outcome Measures :
  1. Patients reported symptoms and problems according to the EORTC QLQ-C30 [ Time Frame: Baseline, 3 weeks and 8 weeks ]
    The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for all the symptoms and problems measured by the EORTC QLQ-C30 and for anxiety and depression measured by the The Hospital Anxiety and Depression Scale (HAD scale)

  2. Survival [ Time Frame: From the start of the trial to minimum three months after the end of the intervention. ]
    Survival.

  3. Economical consequences [ Time Frame: From the start of the trial to minimum three months after the end of the intervention. ]
    Economical consequences measured as the expenses to health care services (treatments, hospitalisation, outpatient visits, emergency room visits, and visits with the general practitioner).

  4. Patient reported Satisfaction with services provided by the health care system measured with the questionnaire FAMCARE-p16 [ Time Frame: 8 weeks ]
    The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) in the patients' evaluation of treatment and care provided by the health care system measured by the FAMCARE-p16 and four additional items developed for this trial


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer stage 4 according to the TNM system (for patients with cancer in CNS inclusion criteria is: cancer grade three or four and no possibility of radical treatment)
  • At least 18 years
  • Live in the area of the participating hospitals
  • No contact with specialised palliative care within the previous year
  • At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
  • Four additional symptoms (defined as patients answering, on average, at least 'a little' in any of the 14 function or symptom scales in the EORTC QLQ-C30 questionnaire)
  • Written informed consent

Exclusion Criteria:

  • Do not understand Danish well enough to participate in the study
  • Are judged incapable of co-operating with the trial protocol
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348048


Locations
Denmark
The Palliative Team, Aarhus University Hospital
Aarhus, Denmark, 8000
Section of Acute Pain Management and Palliative Medicine, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Palliative Medicine, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Palliative Team Herning
Herning, Denmark, 7400
Palliative Team Fyn, Odense University hospital
Nyborg, Denmark, 5800
Palliative Team Vejle
Vejle, Denmark, 7100
Sponsors and Collaborators
Bispebjerg Hospital
TRYG Foundation
Danish Cancer Society
Investigators
Principal Investigator: Mogens Groenvold, MD, PhD, DMSc Department of Palliative Medicine, Bispebjerg Hospital
More Information

Publications:
Responsible Party: Mogens Groenvold, MD, PhD, DMSc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01348048     History of Changes
Other Study ID Numbers: DanPaCT2011
First Posted: May 5, 2011    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015

Keywords provided by Mogens Groenvold, Bispebjerg Hospital:
palliative care
end-of-life care
randomized clinical trial
quality of life
needs assessment
patient satisfaction
cost-effectiveness
Screening

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes